Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Breast Cancer

In brief

Clinical trial in breast cancer patients with bone metastases pretreated for approximately 1 year with a standard zoledronic acid regimen. Looking at the continued effectiveness and safety of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. This study is prospective, double-blind, stratified, multi-center, and two-arm.

Key facts

Study ID

NCT00320710

Run by

Novartis Pharmaceuticals

People needed

416

Starts

2006-02-01

Expected to finish

2013-07-01

Last updated by the study team

2014-08-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients ≥ 18 years of age. Confirmed breast cancer with bone metastasis. Pretreated with Zometa®, or Aredia (pamidronate) or all sequential regimens of both, for a minimum of 9 doses;

You may not qualify if…

• Abnormal kidney function determined by serum creatinine levels. Current active dental problems including: ongoing infection of the teeth or jawbone; current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of the jaw.
• Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants).
• Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of bone).
• Known hypersensitivity to Zometa. Treatment with other investigational drugs within 30 days prior to randomization.
• Other protocol-defined exclusion criteria may have applied.

Where it is running

• Heritage Physicians Group Oncology — Hot Springs, Arkansas, United States
• The Center for Chest Care — Springdale, Arkansas, United States
• Pacific Cancer Medical Center, Inc. — Anaheim, California, United States
• South Bay Oncology Hematology Partners — Campbell, California, United States
• Bay Area Cancer Research — Concord, California, United States
• Pacific Coast Hem/Onc — Fountain Valley, California, United States
• Wilshire Oncology Medical Group — La Verne, California, United States
• Kenmar Research Institute — Los Angeles, California, United States
• North Valley Hematology/Oncology Providence Holy Cross Medical — Northridge, California, United States
• Medical Oncology Care Associates — Orange, California, United States
• Ventura County Hematology and Oncology — Oxnard, California, United States
• The Office of Dr. Swarna Chanduri, MD — Pomona, California, United States
• Access Clinical Research — Rancho Mirage, California, United States
• Cancer and Blood of the Desert — Rancho Mirage, California, United States
• University of California Davis Cancer Center — Sacramento, California, United States
• University of California at Los Angeles — Sylmar, California, United States
• Denver Health Medical Center CACZ885M2301 — Denver, Colorado, United States
• Eastern Connecticut Hematology & Oncology Associates — Norwich, Connecticut, United States
• Georgetown University/Lombardi Cancer Center — Washington D.C., District of Columbia, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Baptist Cancer Center — Jacksonville, Florida, United States
• Pasco Hernando Oncology — New Port Richey, Florida, United States
• The Office of Dr. Elizabeth Tan-Chiu, MD PA — Planatation, Florida, United States
• Suburban Hematology-Oncology — Lawrenceville, Georgia, United States
• Providence Alaska Medical Center Cancer Research — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.